Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Hypoglycemic Agents; Insulin; Insulin, Globin Zinc; Metformin; Secretagogues

Criteria

Inclusion Criteria:

• Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months

• Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.

• Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria

• HbA1c >or= to 7.5% and < or= to 11.0%

• BMI < or = to 40kg/m2.

• FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria:

• Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks

• Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects

• History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings

• Evidence of serious complications of diabetes (e.g. autonomic neuropathy)